Dynamically rigidizing guiderail and methods of use

Abstract

A rigidizing guiderail includes a rigidizing elongate tube having a tubular inner layer, a stiffening layer positioned radially outwards of the tubular inner layer, an outer layer over the tubular inner layer and the stiffening layer, and a vacuum or pressure inlet between the tubular inner layer and tire outer layer and configured to attach to a source of vacuum or pressure. The inner diameter of the tubular inner layer forms a guide wire lumen. The rigidizing elongate tube is configured to have a rigid configuration when vacuum or pressure is applied through the inlet and a flexible configuration when vacuum or pressure is not applied through the inlet.

1 .- 56 . (canceled) 
     
     
         57 . A method of performing a medical procedure, comprising:
 inserting a guidewire into a body lumen to a desired location;   inserting a rigidizing guiderail over the guidewire while the rigidizing guiderail is in a flexible configuration, wherein the rigidizing guidewire comprises a stiffening layer and a bladder layer,   activating pressure or vacuum when the rigidizing guiderail is proximate to the desired location to transition the rigidizing guiderail to a rigid configuration by driving the bladder layer against the stiffening layer,   removing the guidewire from the central lumen; and performing a medical procedure through the central lumen.   
     
     
         58 . The method of  claim 57 , wherein performing a medical procedure comprises inserting a biopsy tool through the central lumen to gather a tissue sample for biopsy. 
     
     
         59 . The method of  claim 57 , wherein performing a medical procedure comprises aspirating a clot through the central lumen. 
     
     
         60 . The method of  claim 57 , wherein the rigidizing guiderail in the rigid configuration has a higher stiffness than the guidewire, and wherein the rigidizing guiderail in the flexible configuration has a lower stiffness than the guidewire. 
     
     
         61 . The method of  claim 57 , further comprising steering the rigidizing guiderail with a steering element while the rigidizing guiderail is positioned over the guidewire. 
     
     
         62 . The method of  claim 57 , further comprising releasing the pressure or vacuum to transition the rigidizing guiderail back to the flexible configuration. 
     
     
         63 . The method of  claim 57 , wherein the rigidizing guiderail has a radial gap of 0.0005″ to 0.006″ around the guidewire. 
     
     
         64 . The method of  claim 57 , wherein the body lumen is a portion of the pulmonary vasculature. 
     
     
         65 . The method of  claim 57 , wherein the body lumen is a portion of the neurovasculature. 
     
     
         66 . The method of  claim 57 , wherein the body lumen is a myocardium. 
     
     
         67 . A method of performing a medical procedure, comprising:
 inserting a guidewire into a body lumen to a desired location;   inserting a rigidizing guiderail over the guidewire while the rigidizing guiderail is in a flexible configuration wherein the rigidizing guidewire comprises a stiffening layer and a bladder layer:   when the rigidizing guiderail is proximate to the desired location, activating pressure or vacuum to transition the rigidizing guiderail to a rigid configuration by driving the bladder layer against the stiffening layer,   passing a catheter over the rigidizing guiderail while the rigidizing guiderail is in the rigid configuration; and   performing a medical procedure using the catheter.   
     
     
         68 . The method of  claim 67 , wherein the rigidizing guiderail in the rigid configuration has a higher stiffness than the guidewire, and wherein the rigidizing guiderail in the flexible configuration has a lower stiffness than the guidewire. 
     
     
         69 . The method of  claim 67 , further comprising steering the rigidizing guiderail with a steering element while the rigidizing guiderail is positioned over the guidewire. 
     
     
         70 . The method of  claim 67 , further comprising rigidizing the catheter by activating pressure or vacuum. 
     
     
         71 . The method of  claim 67 , further comprising inserting a third device through the catheter to perform the medical procedure. 
     
     
         72 . The method of  claim 71 , wherein the third device is an aspiration catheter. 
     
     
         73 . The method of  claim 67 , further comprising releasing the pressure or vacuum to transition the rigidizing guiderail back to the flexible configuration. 
     
     
         74 . The method of  claim 67 , further comprising removing the rigidizing guiderail from the catheter prior to performing the medical procedure. 
     
     
         75 . The method of  claim 67 , wherein the rigidizing guiderail has a radial gap of 0.0005″ to 0.006″ around the guidewire. 
     
     
         76 . The method of  claim 67 , wherein the body lumen is a portion of the pulmonary vasculature. 
     
     
         77 . The method of  claim 76 , wherein performing a medical procedure comprises treating for a pulmonary embolism. 
     
     
         78 . The method of  claim 76 , wherein performing a medical procedure comprises treating chronic thromboembolic pulmonary hypertension (CTEPH). 
     
     
         79 . The method of  claim 67 , further comprising puffing contrast through the rigidizing guiderail to identify a clot. 
     
     
         80 . The method of  claim 67 , wherein performing a medical procedure comprises performing transcatheter aortic valve replacement. 
     
     
         81 . The method of  claim 67 , wherein the body lumen comprises an aortic bifurcation. 
     
     
         82 . The method of  claim 67 , wherein performing a medical procedure comprises an electrophysiology procedure. 
     
     
         83 . The method of  claim 67 , wherein the body lumen is a portion of the neurovasculature. 
     
     
         84 . A method of treating a pulmonary embolism, comprising:
 inserting a guidewire into a body lumen to the pulmonary vasculature proximate to a pulmonary embolism;   inserting a rigidizing guiderail over the guidewire while the rigidizing guiderail is in a flexible configuration, wherein the rigidizing guidewire comprises a stiffening layer and a bladder layer;   transitioning the rigidizing guiderail to a rigid configuration when the rigidizing guiderail is proximate to the pulmonary embolism by driving the bladder layer against the stiffening layer,   passing a catheter over the rigidizing guiderail while the rigidizing guiderail is in the rigid configuration; and   removing at least a portion of the pulmonary embolism through the catheter.